Domestic ViolenceNCT06065865
'Effectively Intervening in Traumatized Parents and Young Children After Structural Domestic Violence: A Multiple Baseline Analysis'
A study testing Guidance document in people with Domestic Violence and PTSD, run by Universiteit Leiden at 1 site in Netherlands.
Trial summary
The goal of this study is to evaluate the effectiveness of an individualized treatment trajectory in which the order of trauma therapy for the parent (Eye movement desensitization and reprocessing (EMDR) therapy), trauma therapy for the child (EMDR therapy) and attachment-based therapy (Dutch short-term intervention… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence, PTSD
- What is being tested?
- Guidance document
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 May 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The non-offending parent and child are residing in a community shelter because of a combination of problems that includes severe domestic violence
- The child is aged between 4-6 years old (if there is more than 1 child in this age range in the family, the parent will be asked to report on the symptoms of both children, and the child with the most severe PTSD symptoms will participate)
- The parent experiences clinically important PTSD-symptoms, as defined by a PCL-score of ≥31
- The child experiences PTSD-symptoms on a clinical level, as defined by a CATS-score of ≥15
Who cannot join
- Parents with extreme mental health problems (e.g., psychosis) that directly affect their ability to participate in an intervention and require immediate intervention for the parent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 'Effectively Intervening in Traumatized Parents and Children After Structural Domestic Violence: A Multiple Baseline Analysis'
The goal of this study is to evaluate the effectiveness of an individualized treatment trajectory in which the order of trauma therapy for the parent (Eye movement desensitization and reprocessing (EMDR) therapy), trauma therapy for the child (EMDR therapy) and attachment-based therapy (Dutch short-term intervention for atypical parenting behavior (NIKA)) is tailored towards the complex needs of victimized parents and their young children (4-6 y/o) after domestic violence. The treatment trajectory is based on a guidance document that supports therapists to determine the optimal order of interventions based on a standardized set of factors. The primary goals of this study are:
- To examine how post-traumatic stress disorder (PTSD)-symptoms of parent and child and parental sensitive and disruptive parenting behavior develop and interact over time, while they follow the individualized treatment trajectory.
- To test whether the start of the treatment trajectory (e.g. the phase in which parents can receive NIKA and EMDR therapy and their child can receive EMDR therapy) leads to a decrease in disruptive parenting behavior towards the child, an increase in sensitive parenting behavior towards the child, and a decrease in PTSD symptoms of the parent in comparison to the baseline phase.
- To test whether the start of the treatment trajectory (e.g. the phase in which children can receive EMDR therapy and their parent can receive NIKA and EMDR therapy) leads to a decrease in PTSD symptoms of the child in comparison to the baseline phase.
Read the detailed description
Rationale:
While the adverse effects of domestic violence on victimized parents and children have been extensively documented, there is still little knowledge on effective intervention approaches for these families. Both parents and children are at risk to develop trauma-related psychopathology after domestic violence. In addition, victimized parents are likely to show disrupted parenting due to their own traumatization (resulting from domestic violence and often also from their own traumatic childhood). This increases the risk for developing a disturbed attachment relationship for the child. Treatment should thus focus at improvement on three levels (parenting behavior and post-traumatic stress (PTSD) symptoms of the parent and the child), and can consist of trauma therapy for parent and child and attachment-based therapy. Since the symptoms in different families may exhibit in different ways, and can interact with each other in a different way, an individualized treatment trajectory that takes these interactions in account may be necessary to allow for maximum symptom reduction.
Study design:
The hypotheses will be tested using a single case experimental design (SCED) study, with a non-concurrent, randomized multiple baseline design. Families who receive treatment after experiencing severe domestic violence will be randomly assigned to a baseline length of 3, 4, 5, 6, 7 or 8 weeks (phase 1), and randomization will occur for two sets of five participants. After the end of the baseline phase, the intervention phase will start, during which dyads will follow an individualized treatment trajectory, consisting of different treatments (phase 2), including EMDR therapy for parent and child to reduce their PTSD symptoms and NIKA to reduce disrupted parenting behavior and increase sensitive parenting behavior. The dyads will participate in weekly appointments throughout the whole duration of the study (both baseline and treatment phase).
Study population:
This study will include 10 parent-child dyads who are residing at a community shelter location in the Netherlands after experiencing domestic violence. Parents with children aged between 4-6 years old will be included if both the parent and the child experience clinically important PTSD-symptoms (based on self-report of the parent). In case that not enough parent-child dyads can be recruited, based on the eligible age range of the child, the age range for the children will be widened, so that children aged between 3-6 years can participate.
- Conditions
- Domestic Violence, PTSD
- Being tested
- Guidance document
- Keywords
- domestic violence, trauma, attachment, individualized treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guidance documentBehavioural
The main intervention of interest is the guidance document, which is explained under 'Arms'. Within the treatment trajectory, that is based on the guidance document, the participants can receive a combination of NIKA, and parent and child can both get EMDR-therapy. The therapies are combined in one treatment trajectory.
NIKA consists of 5 weekly sessions during which participants are videotaped by a trained therapist. The therapist will provide personalized feedback to the parent, which is focused on reducing disrupted parenting behavior and increasing sensitive parenting behavior. EMDR is a brief trauma therapy (in this trial a maximum of six 90-min sessions for the parent and a maximum of six 60-min sessions for the child) aimed at reducing the negative load of the memories of traumatic events. Both parent and child can receive this therapy. During the weekly sessions, the participant is asked to bring the traumatic event to mind while the therapist provides a distracting task.
| Study group | Role | What they receive |
|---|---|---|
| Guidance document | Experimental | The intervention that is investigated in this study is a guidance document, which is used to individualize the treatment trajectory for the parent-child dyad. This guidance document includes different factors that are important in deciding on the order of different types of therapy within one treatment trajectory. The document will guide the therapist in tailoring the treatment trajectory towards the needs of the dyad. The treatment trajectory can consist of EMDR-therapy for the parent, EMDR therapy for the child and NIKA for the parent-child relationship. The guidance document will guide the therapist in deciding on the order of the different therapies. Receives: Behavioral: Guidance document |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disrupted parenting behavior
Behavioral observations from the dyads are videotaped and coded with the 'Atypical Maternal Behavior Instrument for Assessment and Classification'; AMBIANCE (Bronfman et al., 2009-2014). The AMBIANCE is used to score parental behavior on five dimensions. Based on the scores on these dimensions, an overall score of the level of disruption is determined. The overall score is determined in a range between 1-7, where a higher score indicates more disruptive parenting behavior.
Measured: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
Change in sensitive parenting behavior
Behavioral observations from the dyads are videotaped and coded with the 'Ainsworth Maternal Sensitivity Scale' (Ainsworth et al., 1974). Based on this scale, an overall score is given for the sensitivity of the parent towards the child. The score is given on a range between 1-9, where a higher score indicates a higher level of sensitive behavior of the parent towards the child.
Measured: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
Change in PTSD symptoms of the child
Measured with the 'Child and Adolescent Trauma Screen'; CATS (Sachser et al., 2017). The CATS consists of 16 items, and every item can be scored on a scale of 0-3. Participants can score on a range between 0-48, where a higher score indicates that the child has more PTSD-symptoms.
Measured: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
Change in PTSD symptoms of the parent
Measured with the 'PTSD checklist for DSM-5'; PCL-5 (Boeschoten et al., 2014). The PCL-5 consists of 16 items, and every item can be scored on a scale of 0-4. Participants can score on a range between 0-80, where a higher score indicates that the parent has more PTSD-symptoms.
Measured: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
Secondary outcomes (2)
Quality of life of the child
Measured with 6 questions of the Kiddy-KINDL questionnaire (version for 4-6 year-olds) (Villalonga-Olives et al., 2014). Six positively-formulated items of the Kiddy-KINDL will be used. Every item can be answered on a scale of 1-3. Participants can score on a range between 6-18, where a higher score indicates a better quality of life.
Measured: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
Satisfaction with the treatment trajectory
Semi-structured interview with the parent
Measured: Only at the end of the research trajectory (post-test). Depending on the total length of the research trajectory, this will be between 14-25 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start23 May 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The current study has a single case experimental design (SCED), more specifically, a non-concurrent multiple baseline design.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Leiden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lenneke Alink, Universiteit Leiden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065865
- Sponsor's protocol ID
- NL84677.018.23
- Status last verified
- Mar 2025
- First submitted
- 15 Sep 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data and other study materials will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Effectively Intervening in Traumatized Parents and Children After Structural Domestic Violence: A Multiple Baseline Analysis'
- ClinicalTrials.gov ID
- NCT06065865
- Acronym / sponsor ID
- NL84677.018.23
- Conditions
- Domestic Violence, PTSD
- Keywords
- domestic violence, trauma, attachment, individualized treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Universiteit LeidenUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the effectiveness of an individualized treatment trajectory in which the order of trauma therapy for the parent (Eye movement desensitization and reprocessing (EMDR) therapy), trauma therapy for the child (EMDR therapy) and attachment-based therapy (Dutch short-term intervention for atypical parenting behavior (NIKA)) is tailored towards the complex needs of victimized parents and their young children (4-6 y/o) after domestic violence. The treatment trajectory is based on a guidance document that supports therapists to determine the optimal order of interventions based on a standardized set of factors. The primary goals of this study are:
- To examine how post-traumatic stress disorder (PTSD)-symptoms of parent and child and parental sensitive and disruptive parenting behavior develop and interact over time, while they follow the individualized treatment trajectory.
- To test whether the start of the treatment trajectory (e.g. the phase in which parents can receive NIKA and EMDR therapy and their child can receive EMDR therapy) leads to a decrease in disruptive parenting behavior towards the child, an increase in sensitive parenting behavior towards the child, and a decrease in PTSD symptoms of the parent in comparison to the baseline phase.
- To test whether the start of the treatment trajectory (e.g. the phase in which children can receive EMDR therapy and their parent can receive NIKA and EMDR therapy) leads to a decrease in PTSD symptoms of the child in comparison to the baseline phase.
Detailed description
Rationale:
While the adverse effects of domestic violence on victimized parents and children have been extensively documented, there is still little knowledge on effective intervention approaches for these families. Both parents and children are at risk to develop trauma-related psychopathology after domestic violence. In addition, victimized parents are likely to show disrupted parenting due to their own traumatization (resulting from domestic violence and often also from their own traumatic childhood). This increases the risk for developing a disturbed attachment relationship for the child. Treatment should thus focus at improvement on three levels (parenting behavior and post-traumatic stress (PTSD) symptoms of the parent and the child), and can consist of trauma therapy for parent and child and attachment-based therapy. Since the symptoms in different families may exhibit in different ways, and can interact with each other in a different way, an individualized treatment trajectory that takes these interactions in account may be necessary to allow for maximum symptom reduction.
Study design:
The hypotheses will be tested using a single case experimental design (SCED) study, with a non-concurrent, randomized multiple baseline design. Families who receive treatment after experiencing severe domestic violence will be randomly assigned to a baseline length of 3, 4, 5, 6, 7 or 8 weeks (phase 1), and randomization will occur for two sets of five participants. After the end of the baseline phase, the intervention phase will start, during which dyads will follow an individualized treatment trajectory, consisting of different treatments (phase 2), including EMDR therapy for parent and child to reduce their PTSD symptoms and NIKA to reduce disrupted parenting behavior and increase sensitive parenting behavior. The dyads will participate in weekly appointments throughout the whole duration of the study (both baseline and treatment phase).
Study population:
This study will include 10 parent-child dyads who are residing at a community shelter location in the Netherlands after experiencing domestic violence. Parents with children aged between 4-6 years old will be included if both the parent and the child experience clinically important PTSD-symptoms (based on self-report of the parent). In case that not enough parent-child dyads can be recruited, based on the eligible age range of the child, the age range for the children will be widened, so that children aged between 3-6 years can participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The current study has a single case experimental design (SCED), more specifically, a non-concurrent multiple baseline design.
| Arm | Type | Receives |
|---|---|---|
| Guidance document | Experimental | Behavioral: Guidance documentThe intervention that is investigated in this study is a guidance document, which is used to individualize the treatment trajectory for the parent-child dyad. This guidance document includes different factors that are important in deciding on the order of different types of therapy within one treatment trajectory. The document will guide the therapist in tailoring the treatment trajectory towards the needs of the dyad. The treatment trajectory can consist of EMDR-therapy for the parent, EMDR therapy for the child and NIKA for the parent-child relationship. The guidance document will guide the therapist in deciding on the order of the different therapies. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The non-offending parent and child are residing in a community shelter because of a combination of problems that includes severe domestic violence
- The child is aged between 4-6 years old (if there is more than 1 child in this age range in the family, the parent will be asked to report on the symptoms of both children, and the child with the most severe PTSD symptoms will participate)
- The parent experiences clinically important PTSD-symptoms, as defined by a PCL-score of ≥31
- The child experiences PTSD-symptoms on a clinical level, as defined by a CATS-score of ≥15
Key exclusion criteria (1 listed)
- Parents with extreme mental health problems (e.g., psychosis) that directly affect their ability to participate in an intervention and require immediate intervention for the parent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guidance documentThe main intervention of interest is the guidance document, which is explained under 'Arms'. Within the treatment trajectory, that is based on the guidance document, the participants can receive a combination of NIKA, and parent and child can both get EMDR-therapy. The therapies are combined in one treatment trajectory. NIKA consists of 5 weekly sessions during which participants are videotaped by a trained therapist. The therapist will provide personalized feedback to the parent, which is focused on reducing disrupted parenting behavior and increasing sensitive parenting behavior. EMDR is a brief trauma therapy (in this trial a maximum of six 90-min sessions for the parent and a maximum of six 60-min sessions for the child) aimed at reducing the negative load of the memories of traumatic events. Both parent and child can receive this therapy. During the weekly sessions, the participant is asked to bring the traumatic event to mind while the therapist provides a distracting task. | Behavioural | Guidance document |
Primary outcome
Change in disrupted parenting behavior
Time frame: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
Behavioral observations from the dyads are videotaped and coded with the 'Atypical Maternal Behavior Instrument for Assessment and Classification'; AMBIANCE (Bronfman et al., 2009-2014). The AMBIANCE is used to score parental behavior on five dimensions. Based on the scores on these dimensions, an overall score of the level of disruption is determined. The overall score is determined in a range between 1-7, where a higher score indicates more disruptive parenting behavior.
Change in sensitive parenting behavior
Time frame: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
Behavioral observations from the dyads are videotaped and coded with the 'Ainsworth Maternal Sensitivity Scale' (Ainsworth et al., 1974). Based on this scale, an overall score is given for the sensitivity of the parent towards the child. The score is given on a range between 1-9, where a higher score indicates a higher level of sensitive behavior of the parent towards the child.
Change in PTSD symptoms of the child
Time frame: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
Measured with the 'Child and Adolescent Trauma Screen'; CATS (Sachser et al., 2017). The CATS consists of 16 items, and every item can be scored on a scale of 0-3. Participants can score on a range between 0-48, where a higher score indicates that the child has more PTSD-symptoms.
Change in PTSD symptoms of the parent
Time frame: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
Measured with the 'PTSD checklist for DSM-5'; PCL-5 (Boeschoten et al., 2014). The PCL-5 consists of 16 items, and every item can be scored on a scale of 0-4. Participants can score on a range between 0-80, where a higher score indicates that the parent has more PTSD-symptoms.
2 secondary outcomes
Quality of life of the child
Time frame: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.
Satisfaction with the treatment trajectory
Time frame: Only at the end of the research trajectory (post-test). Depending on the total length of the research trajectory, this will be between 14-25 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. Individual participant data and other study materials will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guidance document in people with Domestic Violence and PTSD, run by Universiteit Leiden at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disrupted parenting behavior (time frame: Weekly, from the beginning until the end of the research trajectory. The minimum length of the research trajectories (and thus the number of measurements) is 14 weeks, and the maximum duration is 25 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.